Spinal canal access and probe positioning, devices and methods

• US 8,814,807 B2
• Filed: 08/19/2010
• Issued: 08/26/2014
• Est. Priority Date: 08/19/2009
• Status: Active Grant

• Current Assignee: Medline Industries Incorporated (Medline Holdings Incorporated)
• Original Assignee: Mirador Biomedical Inc.
• Inventors: Hulvershorn, Justin, Schmidt, Karl, Swartz, Douglas
• Primary Examiner(s): Dougherty, Sean
• Assistant Examiner(s): Stout, Michael C
• Application Number:
  US12/806,747
• Publication Number:
  US 20110054353A1
• Time in Patent Office: 1,468 Days
• Field of Search: 600/561, 600/573
• US Class Current: 600/561
• CPC Class Codes: A61B 17/3401 Puncturing needles for the peridural or subarachnoid space or the plexus, e.g. for anaesthesia local anaesthesia A61M19/00
• CPC Class Codes: A61B 2090/034 abutting on parts of the device itself
• CPC Class Codes: A61B 2090/065 for measuring contact or contact pressure
• CPC Class Codes: A61B 5/032 Spinal fluid pressure
• CPC Class Codes: A61B 5/036 by means introduced into body tracts A61B5/032 and A61B5/035 take precedence
• CPC Class Codes: A61B 5/065 Determining position of the probe employing exclusively positioning means located on or in the probe, e.g. using position sensors arranged on the probe
• CPC Class Codes: A61B 5/4821 Determining level or depth of anaesthesia A61B5/1106 takes precedence
• CPC Class Codes: A61M 25/06 Body-piercing guide needles or the like
• CPC Class Codes: A61M 25/0693 Flashback chambers

Abstract

Methods and devices for detecting positioning of a probe in a tissue of a patient. A method can include providing a detection device; advancing a device coupled probe through the tissue of the patient and toward the patient'"'"'s spinal canal; detecting a change in pressure about the distal portion of the coupled probe during advancing, where the detected pressure change indicates probe positioning in the patient'"'"'s spinal canal; outputting the detected pressure change or indication of probe positioning to a visual display.

Claims

1. A method for detecting positioning of a probe in a tissue of a patient having a spinal canal, comprising:

providing a device comprising a housing having a proximal portion and a distal portion, the distal portion coupled to the probe, the device further comprising;

a tissue pressure sensing system at least partially carried by the housing and comprising a processing unit coupled with a pressure sensor, the processing unit configured to receive tissue pressure signals comprising a series of instantaneous tissue pressure values from the pressure sensor and determine a mean tissue pressure value over a predetermined period of time with a moving average of the series, the mean tissue pressure value indicative of a tissue environment about a distal portion of the coupled probe; and

an output unit carried by the housing and comprising a visual display, the output unit coupled to the pressure sensing system so as to receive the mean tissue pressure value signal and output to the visual display the determined mean tissue pressure value, thereby indicating positioning of the probe in the tissue of the patient;

advancing the output unit and the probe distally such that a distal portion of the probe advances through the tissue of the patient and toward the patient'"'"'s spinal canal with the mean tissue pressure shown on the visual display; and

detecting a change in the mean tissue pressure value about the distal portion of the coupled probe during said advancing indicating probe positioning in the patient'"'"'s spinal canal.

2. The method of claim 1, wherein the probe is rigidly coupled to the device so as to allow positioning of probe by position manipulation of the device housing by a user.

3. The method of claim 1, wherein the probe is directly coupled to the device.

4. The method of claim 1, comprising coupling the probe to the distal portion of the device following insertion of the probe into ligament tissue in the patient'"'"'s back tissue.

5. The method of claim 1, wherein advancing the device comprises entering the probe into epidural space of the patient'"'"'s spinal canal.

6. The method of claim 5, further comprising introducing pressure into the device prior to and/or while advancing the probe into the epidural space.

7. The method of claim 6, detecting a decrease in detected mean pressure as indication of entry into the epidural space.

8. The method of claim 5, detecting a pressure waveform indicating positioning of the probe in the epidural space.

9. The method of claim 5, introducing an epidural catheter through the probe following detection of entry into the epidural space.

10. The method of claim 1, wherein advancing the device comprises advancing the probe through dura and entering into the subarachnoid space.

11. The method of claim 10, comprising detecting an increase in pressure as an indication of entry into the subarachnoid (CSF) space.

12. The method of claim 10, comprising detecting a pressure waveform indicating positioning of the probe in the CSF space.

13. The method of claim 10, further comprising flowing fluid into the probe, device or coupled syringe for cerebrospinal fluid (CSF) collection or further indication of probe positioning.

14. The method of claim 10, further comprising monitoring pressure of the CSF during a fluid collection.

15. The method of claim 14, further comprising discontinuing fluid collection in response to detected pressure readings.

16. The method of claim 10, detecting CSF pressure indicative of a pathological condition.

27. The method of claim 5, further comprising aspirating the probe to determine a presence or absence of CSF or blood fluid.

34. The method of claim 1, wherein said detecting a change in mean pressure includes detecting a mean anatomical pressure about the distal portion of the coupled probe.

17. A device for detecting positioning of a coupled probe in a tissue of a patient, the device comprising:

a housing having a distal portion with a first port that is detachably couplable to a probe, and a proximal portion, the housing graspable with a hand of a user to advance the housing and the probe toward the tissue;

a tissue pressure sensing system at least partially carried by the housing and comprising a processing unit coupled with a pressure sensor, the processing unit configured to receive tissue pressure signals comprising a series of instantaneous tissue pressure values from the pressure sensor and determine from the received signals a mean tissue pressure value over a predetermined period of time with a moving average of the series, the mean tissue pressure value indicative of a tissue environment about a distal portion of the coupled probe, the predetermined period of time selected such that the mean tissue pressure value is indicative of a position of the distal portion of the coupled probe during positioning in tissue; and

an output unit carried by the housing and comprising a visual display, the output unit coupled to the pressure sensing system so as to receive the mean tissue pressure value and output to the visual display a reporting signal indicating the determined mean tissue pressure value, thereby indicating positioning of the probe in the tissue of the patient.

18. The device of claim 17, further comprising a memory having instructions that when executed cause the processing unit to process one or more signals received from the pressure sensor to determine a change in mean pressure indicative of i) entry into epidural space;

ii) entry into CSF space;

iii) a pressure waveform characteristic of a patient'"'"'s spinal canal;

or iv) a combination thereof.

19. The device of claim 17, wherein the device is sized for hand-held use by a medical provider.

20. The device of claim 19, the housing comprising a gripping portion with the display carried by the housing on a side generally opposite the gripping portion.

21. The device of claim 19, wherein the visual display is angled proximally relative to a long axis of the devices.

22. The device of claim 17, the proximal portion of the housing comprising a second port that is detachably couplable to a syringe, and the first port fluidly coupled to the second port.

23. The device of claim 22, further comprising a probe coupled to the first port and a syringe coupled to the second port such that the probe, device, and syringe are arranged axially and in sequence.

24. The device of claim 17, the probe comprising an epidural needle or a lumbar puncture needle.

25. The device of claim 17, further comprising a pressure relief or buffer system structured to accommodate non patient-anatomical fluctuations of pressure in the device.

26. The device of claim 25, the pressure relief or buffer system comprising a reservoir disposed between a pressure tube and a fluid channel.

28. A device for detecting positioning of a coupled probe in a tissue of a patient, the device comprising:

a tissue pressure sensing system at least partially carried by a housing and comprising a processing unit coupled with a pressure sensor, the housing graspable with a hand of a user and couplable to a probe having a distal portion, the processing unit configured to receive a plurality of pressure signals comprising a series of instantaneous tissue pressure values from the pressure sensor and determine from the plurality of pressure signals a mean tissue pressure value over a predetermined period of time with a moving average of the series selected such that the mean tissue pressure value is indicative of a position of the distal portion of the coupled probe during positioning in tissue; and

an output unit carried by the housing and comprising a visual display, the output unit coupled to the pressure sensing system so as to receive the mean tissue pressure value and the series of instantaneous tissue pressure values and output to the visual display the determined mean tissue pressure value and the series of instantaneous pressure values, thereby indicating positioning of the probe in the tissue of the patient,

wherein the visual display comprises a readout display carried with the housing for displaying both the determined mean tissue pressure value and the series of instantaneous tissue pressure values in order to position the probe with movement of the housing and the readout display.

29. A device for positioning a probe in tissue of a patient, the device comprising:

a housing comprising a gripping portion and having a distal portion with a first port that is detachably coupleable to a probe such that the probe is rigidly attached to the distal portion, and a proximal portion having a second port fluidly coupled to the first port, wherein the first port and second port are disposed on the housing such that the coupled probe, device and second port are arranged axially and in sequence;

a tissue pressure sensing system at least partially carried by the housing and comprising a processing unit coupled with a pressure sensor to receive a plurality of pressure signals comprising a series of instantaneous pressure values from the pressure sensor and determine from the plurality of pressure values a mean tissue pressure value over a predetermined period of time with a moving average of the series, the mean tissue pressure value indicative of a tissue environment about a distal portion of the rigidly coupled probe, the predetermined period of time being selected such that the mean tissue pressure value is indicative of a position of the distal portion of the coupled probe during positioning in tissue; and

an output unit carried by the housing and comprising a visual display carried by the housing, the output unit coupled to the pressure sensing system so as to receive the mean tissue pressure value and output to the visual display the mean tissue pressure value determined with the moving average of the series, thereby indicating positioning of the probe in the tissue of the patient.

30. The device of claim 29, wherein:

the proximal portion of the housing comprising a second port that is detachably couplable to a syringe; and

the first port is fluidly coupled to the second port.

31. The device of claim 30, further comprising a probe coupled to the first port and a syringe coupled to the second port such that the probe, device, and syringe are arranged axially and in sequence.

32. The device of claim 29, wherein the reporting signal is continuously updated in real time or near real time.

33. The device of claim 29, wherein the mean pressure value is determined by averaging a series of instantaneous pressure values sensed by the pressure sensor.